退行性半月板撕裂患者理療與關節(jié)鏡下手術療效的前瞻性比較研究

付東 單連成 蔡鄭東 李國東

. 膝關節(jié)外科 Knee surgery .

退行性半月板撕裂患者理療與關節(jié)鏡下手術療效的前瞻性比較研究

付東 單連成 蔡鄭東 李國東

目的評估針對退行性半月板撕裂，聯(lián)合關節(jié)鏡手術與理療療效是否優(yōu)于單純理療。方法40 例年齡＞50歲，經(jīng)磁共振 (MRI ) 確診為半月板撕裂患者根據(jù)數(shù)字隨機法分為兩個治療組。一組接受關節(jié)鏡手術治療 (關節(jié)鏡手術＋理療組 ) 20 例，術后實施物理治療；另一組接受單純物理治療方案 (物理治療組 ) 20 例。治療方案完成后 6、12、24 個月，比較兩組在膝關節(jié)損傷與骨關節(jié)炎評分 (knee injury and osteoarthritis outcome score，KOOS ) 方面的差異。結果治療后 6 個月，手術治療組和物理治療組疼痛、運動和娛樂、日常活動和 KOOS 總分評分均較術前明顯改善，差異有統(tǒng)計學意義，其中物理治療組疼痛由術前 46.35 改善至40.10 (P＜0.001 )、運動和娛樂 21.45 上升至 42.60 (P＜0.0001 )、日?；顒佑?27.85 上升至 41.75 (P＜0.0001 )、KOOS 總分從 26.12 提高至 46.85 (P＜0.0001 )；鏡下手術組疼痛由 47.05 改善至 33.25 (P＜0.0001 )、運動和娛樂由 21.55 上升至 38.10 (P＝0.002 )、日?；顒佑?26.00 上升至 46.84 (P＜0.0001 )、KOOS 總分由 23.05 上升至 39.26 (P＜0.0001 )。治療后 12 個月與 6 個月相比，臨床癥狀進一步緩解，差異有統(tǒng)計學意義，物理治療組疼痛降至 29.20 (P＜0.0001 )、運動和娛樂 (P＝0.007 )、日?；顒?(P＜0.0001 )、KOOS 總分 (P＝0.001 ) 分別上升至 53.16、53.10、50.90；鏡下手術組疼痛降至 24.55 (P＜0.001 )、運動和娛樂 (P＜0.0001 )、日常活動(P＜0.0001 )、KOOS 總分 (P＜0.0001 ) 分別改善至 54.10、57.65、50.77。治療后 24 個月，患者各項評分與術后 12 個月基本持平。不同隨訪階段，盡管手術組整體評分優(yōu)于物理治療組，差異并無統(tǒng)計學意義 (P＞0.05 )。結論隨訪2 年，未發(fā)現(xiàn)兩組治療后在功能改善和疼痛緩解方面存在顯著差異，物療治療應視為退行性半月板撕裂的首選治療方案。

半月板，脛骨；關節(jié)鏡；膝損傷；前瞻性研究；康復；膝關節(jié)

隨著影像學技術的發(fā)展，越來越多受膝關節(jié)疼痛和功能受限困擾的中年患者經(jīng) MRI 診斷為非創(chuàng)傷性、退行性半月板撕裂，部分伴有退行性骨關節(jié)炎。但就治療而言，退行性半月板撕裂到底是否需要關節(jié)鏡手術還是保守療法即可，臨床一直都存在爭議。Jeffrey 等[1]和 Herrin 等[2]報道，退行性內(nèi)側(cè)半月板撕裂，伴有輕度骨關節(jié)炎患者，經(jīng)關節(jié)鏡下手術＋物理治療和單純物理治療組，隨訪期間發(fā)現(xiàn)療效并無差異。國內(nèi)尚未見報道。本研究旨在評估針對中老年退行性半月板撕裂，關節(jié)鏡手術＋物理治療與單純物理治療相比是否具有優(yōu)勢。假設關節(jié)鏡手術對患者康復無顯著影響。

資料與方法

一、一般資料

2009 年 9 月至 2012 年 9 月，共經(jīng)治 40 例。入院時根據(jù)數(shù)字隨機法分為關節(jié)鏡下手術＋物理治療組 (簡稱：鏡下手術組 )、單純物理治療組 (簡稱：物理治療組 ) 兩組，每組 20 例。本組 40 例全部完成治療計劃，并獲隨訪。本研究通過上海市第十人民醫(yī)院倫理委員會審核。所有患者充分告知研究內(nèi)容并簽署知情同意書。

1. 入選標準：(1) 年齡 50～60 歲；(2) 近3 個月持續(xù)的膝關節(jié)疼痛和 (或 ) 關節(jié)活動受限；(3) 否認外傷病史；(4) 經(jīng) MRI 證實為半月板撕裂 (可伴有輕度骨關節(jié)炎 )。

2. 排除標準：(1) 有明確外傷史；(2) 合并嚴重的骨關節(jié)炎或類風濕關節(jié)炎等：(3) 合并膝關節(jié)不穩(wěn)、韌帶損傷、髕股關節(jié)炎等；(4) 既往患側(cè)膝關節(jié)手術史。

所有患者在治療前和治療后第 6、12、24 個月患側(cè)膝關節(jié)攝 X 線片評估骨關節(jié)炎變化。此外，還需按要求填寫 KOOS 問卷[3]。以門診隨訪，電話回訪和信件寄回的形式獲得問卷結果。這個評分主要包括五個方面：日常活動 (17 項 )，疼痛 (9 項 )，運動和娛樂功能 (7 項 )，癥狀 (7 項 ) 和膝關節(jié)相關的生活質(zhì)量 (4 項 )。每個問題被分為 0～4 五個等級，每個方面得分和總分轉(zhuǎn)化為標準分 (0～100 )。本研究僅對 KOOS 前3 項內(nèi)容及相應總分進行比較，分值越高，說明患者癥狀越重。

由同一名高年資醫(yī)師完成 20 例關節(jié)鏡手術。所有患者術中采用腰麻和標準膝前入路，術中依次探查髕股關節(jié)、內(nèi)外側(cè)半月板、十字韌帶、股骨內(nèi)外側(cè)髁及髁間窩。休整半月板撕裂的邊緣，清除關節(jié)內(nèi)游離體和碎片。充分負壓吸引關節(jié)腔內(nèi)積液后，注射利多卡因5 ml，復方倍他米松注射液1 ml，玻璃酸鈉 40 ml。加壓包扎。術后患者如能耐受疼痛可自行下地活動，不使用保護性支具。

理療由我院康復科醫(yī)師指導完成。兩組患者接受相同的康復訓練。每周進行2 次康復治療，平均治療時間為2 個月。具體理療方案參照 Herrin 提出的康復流程[4]。

二、統(tǒng)計分析

分別于術前、術后 6、12、24 個月時，記錄患者 KOOS 每個方面得分和總分并匯總轉(zhuǎn)化為標準分。所有數(shù)據(jù)以平均值±標準差 (±s) 表示，統(tǒng)計學分析借助 STATA 11 (College Station，Texas 77845USA ) 進行分析。所得定量數(shù)據(jù)采用配對 t 檢驗分析，定性數(shù)據(jù)采用卡方檢驗。P＜0.05 認為差異有統(tǒng)計學意義。

結 果

本組 40 例均獲得平均 27 (10～46 ) 個月的隨訪。手術治療組男女比例為 9 / 11，平均年齡(55.1±2.55 ) 歲，術前 13 例合并輕度骨關節(jié)炎；物理治療組男女比例為 7 / 13，平均年齡 (53.2±2.78 )歲，術前 10 例合并輕度骨關節(jié)炎。兩組性別、年齡、合并骨關節(jié)炎人數(shù)所占比例差異均無統(tǒng)計學意義 (P＞0.05 )，具有可比性。

兩組術前疼痛、運動和娛樂、日?；顒雍?KOOS總分評分差異均無統(tǒng)計學意義。術后 6、12 個月，手術治療組和物理治療組評分均較術前明顯改善，差異有統(tǒng)計學意義；治療后 12 個月所測得評分與術后 6 個月相比，各項參數(shù)值仍然持續(xù)下降，總的下降趨勢不如術前 6 個月明顯。治療后 24 個月，患者各項主述癥狀與術后 12 個月相比差異無統(tǒng)計學意義。在比較不同隨訪階段兩組各項參數(shù)差異過程中，結果發(fā)現(xiàn)盡管手術組整體評分均優(yōu)于物理治療組，但差異并無統(tǒng)計學意義 (表1) (圖 1，2 )。

圖1 各階段疼痛、運動和娛樂分值變化 P (Physiotherapy ), P+A (Physiotherapy+Arthroplasty )Fig.1 The score changes of the pain and sports and entertainment at different stages P referred to Physiotherapy, and P+A referred to Physiotherapy+Arthroplasty

圖2 各階段日常生活、KOOS 總分分值變化 P (Physiotherapy ), P+A (Physiotherapy+Arthroplasty )Fig.2 The score changes of the daily activities and KOOS at different stages P referred to Physiotherapy, and P+A referred to Physiotherapy+Arthroplasty

表1 患者術前、術后 KOOS 評分數(shù)據(jù) (±s)Tab.1 The KOOS scores of the patients before and after the operation (±s)

表1 患者術前、術后 KOOS 評分數(shù)據(jù) (±s)Tab.1 The KOOS scores of the patients before and after the operation (±s)

注：治療前與隨訪 KOOS 各項評分 (均數(shù)和標準差 )。a隨訪 6 個月與治療前比較；b隨訪 12 個月與隨訪 6 個月比較；c隨訪 24 個月與隨訪 12 個月比較Notice: The KOOS scores of all the items before the treatment and during the follow-up (means & standard deviations).aReferred to the differences at 6 months after the treatment and before the treatment.bReferred the differences at 12 and 6 months after the treatment.cReferred to the differences at 24 and 12 months after the treatment

變量評分 物理治療組 鏡下手術組 P 值治療前疼痛 46.35±24.64 47.05±17.35 0.09運動和娛樂 21.45± 7.25 21.55± 8.10 0.97日?；顒?27.85± 8.05 26.00± 8.58 0.53 KOOS 總分 26.12± 5.53 23.05± 5.64 0.65隨訪 6 個月疼痛 40.10±16.64 (P＜0.0001 )a 33.25±12.25 (P＜0.0001 )a0.13運動和娛樂 42.60± 8.14 (P＜0.0001 )a 38.10± 7.91 (P=0.0002 )a 0.86日常活動 41.75± 9.39 (P＜0.0001 )a 46.84± 8.19 (P＜0.0001 )a 0.63 KOOS 總分 46.85± 6.69 (P＜0.0001 )a 39.26± 5.99 (P＜0.0001 )a 0.16隨訪 12 個月疼痛 29.20±10.91 (P＜0.0001 )b 24.55± 9.70 (P＜0.0001 )b0.09運動和娛樂 53.16±12.78 (P=0.007 )b 54.10±14.03 (P＜0.0001 )b 0.22日?；顒?53.30±12.58 (P＜0.0001 )b 57.65±13.91 (P＜0.0001 )b 0.93 KOOS 總分 50.93± 8.84 (P=0.001 )b 50.77± 6.90 (P＜0.0001 )b 0.95隨訪 24 個月疼痛 28.25±10.31 (P=0.17 )c 21.20± 9.16 (P=0.10 )c0.06運動和娛樂 54.90±14.80 (P=0.15 )c 56.20±17.36 (P=0.12 )c 0.18日?；顒?55.71±17.17 (P=0.32 )c 57.10±17.82 (P=0.74 )c 0.79 KOOS 總分 52.98±13.31 (P=0.42 )c 53.45± 9.36 (P=0.31 )c 0.90

討 論

在美國，每年有癥狀，且經(jīng)影像學證實的膝關節(jié)骨關節(jié)炎患者約有 900 萬例[5]。50 歲以上的人群中，半月板撕裂者高達 35%，其中三分之二都沒有癥狀[6]。半月板損傷在患有骨關節(jié)炎的患者中患病率尤其高[7-8]，臨床通常都進行關節(jié)鏡下的半月板部分切除。該手術方式主要通過休整撕裂的半月板，使其邊緣變得穩(wěn)定、平整。同樣參照美國的數(shù)據(jù)，每年約有 46.5 萬例接受這一手術[9]。既往 Kirkley等[10]和 Mosely 等[11]報道，關節(jié)鏡手術治療退行性骨關節(jié)炎，在給患者造成經(jīng)濟損失的同時并沒有帶來相應的臨床療效。而對于退行性半月板撕裂患者，是否具有關節(jié)鏡手術指征以及術后療效如何？尚有爭議。

Jeffrey 等[1]在一項多中心隨機對照研究中發(fā)現(xiàn)，年齡超過 45 歲伴有退行性半月板撕裂和輕中度半月板撕裂患者分別經(jīng)關節(jié)鏡手術＋理療和單純理療后 6、12 個月，患者膝關節(jié)功能和疼痛較治療前明顯改善，組間差異無統(tǒng)計學意義。盡管如此，他們還發(fā)現(xiàn) 35% 原先在的物理治療組患者最終選擇手術治療，具體原因并未提及。另一項類似隨機對照實驗來自于 Herrlen 等[2]，5 年隨訪結果，顯示兩組患者治療后關節(jié)功能和疼痛改善情況有差異，但無統(tǒng)計學意義。本研究與上述兩項研究所得出的結論保持一致。

由于半月板撕裂合并膝關節(jié)骨關節(jié)炎的患病率很高，并且兩者都有可能沒有任何癥狀，這對于臨床決策來說是一個挑戰(zhàn)，即使患者出現(xiàn)明顯的臨床癥狀，其癥狀是來自半月板撕裂，還是骨關節(jié)炎；或者兩者兼有？排除術后功能恢復和疼痛改善的差異性，與手術＋理療相比，單純理療最明顯的優(yōu)勢為減少手術帶來的創(chuàng)傷和相關醫(yī)療費用。就 50 歲以上合并退行性半月板撕裂術后影像學評估，目前國內(nèi)外尚無相關報道，后期我們將通過術后 MRI 檢查隨訪患者半月板修復情況及其與疼痛和功能的相關性，進一步證實關節(jié)鏡手術治療退行性撕裂半月板的可行性及效價比。

通過以上研究，對于有臨床癥狀且影像學證實退行性、非創(chuàng)傷性半月板撕裂伴或不伴有骨關節(jié)炎患者，關節(jié)鏡手術和理療在隨訪期間都能較好地改善功能、緩解疼痛。也就是說，對于這一類的患者，關節(jié)鏡手術雖不是首選或者惟一的治療選擇，但仍是可行的治療方案，尤其對于理療等非手術治療無效的患者。

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(本文編輯：李貴存 )

A prospective and comparative study of either physiotherapy along or accompanied arthroscopic surgery for degenerative meniscal tears

FU Dong, SHAN Lian-cheng, CAI Zheng-dong, LI Guo-dong. Department of Orthopaedics, Shanghai tenth People’s Hospital, Tongji University, Shanghai, 200072, PRC

ObjectiveTo evaluate whether physiotherapy along was superior to physical therapy accompanied by arthroscopic surgery in the treatment of degenerative meniscal tears. Methods A total of 40 patients of more than 50 years old were diagnosed as meniscal tears based on Magnetic Resonance Imaging (MRI ), and then were divided into2 treatment groups. The patients in the physical therapy accompanied by arthroscopic surgery group (n=20 ) received arthroscopic surgery and then postoperative physical therapy, and the patients in the physical therapy group (n=20 ) received physical therapy alone. The differences in the Knee Injury and Osteoarthritis Outcome Score (KOOS ) were compared between the2 groups at 6, 12 and 24 months after the treatment. Results At 6 months after the treatment, the pain, sports and entertainment, daily activities and KOOS scores both in the physical therapy accompanied by arthroscopic surgery group and in the physical therapy group were obviously improved when compared with the preoperative scores, and the differences between them were statistically signifcant. In the physical therapy group, the pain scores was improved from 46.35 points to 40.10 points (P＜0.001 ), the sports and entertainment scores from 21.45 points to 42.60 points (P＜0.0001 ), the scores of daily activities from 27.85 points to 41.75 points (P＜0.0001 ) and the total KOOS from 26.12 points to 46.85 points (P＜0.0001 ). In the physical therapy accompanied by arthroscopic surgery group, the pain scores was improved from 47.05 points to 33.25 points (P＜0.0001 ), thesports and entertainment scores from 21.55 points to 38.10 points (P=0.002 ), the scores of daily activities from 26.00 points to 46.84 points (P＜0.0001 ) and the total KOOS from 23.05 points to 39.26 points (P＜0.0001 ). The clinical symptoms at 12 months after the treatment were further improved when compared with that at 6 months after the treatment, and the differences between them were statistically signifcant. In the physical therapy group, the pain scores was changed to 29.20 points (P＜0.0001 ), the sports and entertainment scores to 53.16 points (P=0.007 ), the scores of daily activities to 53.10 points (P＜0.0001 ) and the total KOOS to 50.90 points (P=0.001 ). In the physical therapy accompanied by arthroscopic surgery group, the pain scores was changed to 24.55 points (P＜0.001 ), the sports and entertainment scores to 54.10 points (P＜0.0001 ), the scores of daily activities to 57.65 points (P＜0.0001 ) and the total KOOS to 50.77 points (P＜0.0001 ). The scores of various items at 24 months after the treatment were almost equal to the scores at 12 months after the treatment. Although the overall scores in the physical therapy accompanied by arthroscopic surgery group were superior to that in the physical therapy group at different followup stages, the differences between them were not statistically signifcant (P＞0.05 ).ConclusionsDuring the 2-year follow-up, no statistically signifcant differences are found in the functional improvement or pain relief between the2 groups. Physical therapy should be considered as the preferred treatment choice for degenerative meniscal tears.

Meniscus, tibia; Arthroscope; Knee injury; Prospective study; Rehabilitation; Knee joint

10.3969/j.issn.2095-252X.2014.06.006

R687.4

200072 上海，同濟大學附屬第十人民醫(yī)院骨科 (付東，單連成，蔡鄭，李國東 )；200092 上海，同濟大學生命科學與技術學院生物醫(yī)學工程博士后流動站 (單連成 )

李國東，Email: tutumi89@126.com

2013-10-20 )